Quality Manager (Medical Devices)

Purpose of the job: 

• Supervise quality control, quality assurance, validation activities and ensures the proper implementation of quality system.
• Monitor the quality system effectiveness and ensures that the products/Processes & materials meet the highest recognizable international quality standards and regulatory standards.

Description:

• Prepares and implements the quality department policy.
• Supervises the quality control, quality assurance and validation activities.
• Approves sampling instructions, specifications, test methods and other quality control procedures.
• Reviews and evaluates batch records.
• Ensures that operations are performed according to GMP.
• Ensure that appropriate validations, including those of analytical procedures and calibration of equipment are done.
• Prepares Tichnical Files for all products.
• Prepares and submits registration files for products to MOH.
• Ensures that the required initial and continuing training of quality control and quality assurance personnel is carried out and adapted according to needs.
• Prepare Internal Audit Plan,  supervises the Internal Audit Activities and manage the external audit activities.
• Ensures that the quality system requirements are meet.
• Handle customer complaints.
• Follow up product recall and deals with complaints effectively and determine root cause, corrections and corrective actions.
• Handles products release as required.
• Ensures the implementation of quality system according to ISO and CE requiements.
• Responsible for quality and manufacturing records retention.
• Responsible to design and monitoring of storage conditions of materials and products.
• Ensure the continuous monitoring and control of production environments.
• Approve of quality department documentation.
• Any other requirements From Direct Manager.